COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Disclaimer: Comments provided during the consultation are made available as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a substance of very high concern. 

Substance name: 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol
CAS number: 79-94-7
EC number: 201-236-9

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carcinogenic (Article 57a)

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5625
2022/10/12	Company,
Finland	NA	Thank you for your information regarding compliance. 	
		Attachment: 5625_LEDiL RoHs and REACH Compliance Statement Of Restricted Substances and POP_03082022.pdf
		
5657
2022/10/16	American Chemistry Council North American Flame Retardant Alliance,
Industry or trade association,
United States of America		Thank you for your comments and the information provided.  Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an SVHC is based on the intrinsic properties of the substance.

		Attachment: 5657_NAFRA Comments on ECHA SVHC Proposal for TBBPA FINAL - 10_15_2022.pdf
		
5683
2022/10/17	ICL-IP Europe Coöperatief U.A. ,
Other contributor,
Netherlands	see for further comments on the Annex XV report, the enclosed comment paper	Thank you for your comments and the information provided.  Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, since identification of an SVHC is based on the intrinsic properties of the substance.

As described in the Restrictions Roadmap, "ECHA, Member States and COM are currently assessing the need for further regulatory management measures on flame retardants. ECHA will prepare an overall strategy on flame retardants by 2022, which will support COM when it decides to request (a) restriction dossier(s)." We support this way forward and will not initiate other risk management measures on TBBPA, at this time.	
		Attachment: 5683_2022-10-17 TBBPA ICL Response to Annex XV.pdf

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5613
2022/10/10	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks Norway for its proposal to identify 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol (TBBPA) as a substance of very high concern (SVHC) due to its carcinogenic properties under REACH article 57(a).

Because ECHA’s Risk Assessment Committee suggested that the substance should be classified as a carcinogen 1B in September 2021 under the CLP regulation (regulation 1272/2008) and that it is included in the 21st ATP to CLP, we consider the proposed SVHC identification unequivocal.

	Thank you for your support.	
				
5625
2022/10/12	Company,
Finland	NA	Thank you for your information regarding compliance.	
		See the corresponding embedded attachment in table 1 of Part I: 5625_LEDiL RoHs and REACH Compliance Statement Of Restricted Substances and POP_03082022.pdf		
5637
2022/10/14	Germany,
Member State	The German CA supports the proposal to identify 2,2',6,6'-tetrabromo-4,4'-isopropylidenedi-phenol as SVHC based on its classification as Carc 1B.	Thank you for your support.	
				
5657
2022/10/16	American Chemistry Council North American Flame Retardant Alliance,
Industry or trade association,
United States of America	Due to diagrams and references included in our comments, they are attached for reference in review.	Thank you for the comments. Please see our response above. 	
		See the corresponding embedded attachment in table 1 of Part I: 5657_NAFRA Comments on ECHA SVHC Proposal for TBBPA FINAL - 10_15_2022.pdf		
5682
2022/10/17	Anses,
National Authority,
France	The harmonised classification carcinogenic category 1B. of
2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol fulfils the criteria to identify the substance as an SVHC under article 57(a) and the SVHC identification is supported.

	Thank you for your support.	
				
5683
2022/10/17	ICL-IP Europe Coöperatief U.A. ,
Other contributor,
Netherlands	See for comments on Part 1 , the enclosed comment paper	Thank you for the comments. Please see our response above 	
		See the corresponding embedded attachment in table 1 of Part I: 5683_2022-10-17 TBBPA ICL Response to Annex XV.pdf		
5689
2022/10/17	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of this substance as a vPvB.We added it to the SIN List in 2014, and since the evidence of vPvB properties have grown further. It especially concerning that this substance is allready widespread in the environment.	This proposal concerns TBBPA as a carcinogen cat. 1B.	
				
5717
2022/10/17	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of tetrabromobisphenol-A (TBBPA)in the REACH candidate list based on its classification as a carcinogen category 1B in accordance with Article 57 (c) of REACH.	Thank you for your support.	
				
5724
2022/10/17	European Environmental Bureau (EEB),
International NGO,
Belgium	The EEB thanks Norway for the proposal to identify  2,2',6,6'-tetrabromo- 4,4'-isopropylidenediphenol (TBBPA) as Substance of Very High Concern according to REACH Article 57 (a) due to its classification in the hazard class carcinogenicity category 1B by RAC and its inclusion in the draft 21st ATP to CLP. TBBPA is the most widely used brominated flame retardant in the world and registered under REACH at 10.000 - 100.000 tpa and has wide dispersive uses by consumers and professional users in the EU. The substance should be added to the Candidate List and TBBPA and its derivatives should be prioritised for further regulatory risk management measures as proposed in ECHA’s Assessment of regulatory needs for TBBPA and its derivatives.	Thank you for your support.
According to the Restrictions Roadmap from COM, ECHA, Member States and COM are currently assessing the need for further regulatory management measures on flame retardants. ECHA will prepare an overall strategy on flame retardants by 2022, which will support COM when it decides to request (a) restriction dossier(s). The substances in scope are in principle all flame retardants, and there will be particular focus on brominated flame retardants and their prioritisation for restrictions.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5625
2022/10/12	Company,
Finland	NA	Thank you for your information regarding compliance.	
		See the corresponding embedded attachment in table 1 of Part I: 5625_LEDiL RoHs and REACH Compliance Statement Of Restricted Substances and POP_03082022.pdf		
5657
2022/10/16	American Chemistry Council North American Flame Retardant Alliance,
Industry or trade association,
United States of America		Thank you for the comments. Please see our response above.	
		See the corresponding embedded attachment in table 1 of Part I: 5657_NAFRA Comments on ECHA SVHC Proposal for TBBPA FINAL - 10_15_2022.pdf		
5676
2022/10/17	European Automobile Manufacturers' Association (ACEA),
Industry or trade association,
Belgium	TBBPA is used extensively in the automotive industry as a reactive flame retardant, the majority of which are in electrical or electronic applications. Its usage is essential in meeting flammability requirements, protecting our customers and saving lives. In epoxy and polycarbonate resins (our main applications) reactive TBBPA flame retardant is the only choice available and its continued use is indispensable to our industry.
 
As it is a reactive flame retardant, TBBPA does not exist in the final product, as it is consumed in the reaction with the epoxy resin.  It is classed as an intermediate use according to REACH and will not be subject to Authorisation.
 
Initial investigation shows that a minimum of 95% of automotive uses are as a reactive flame retardant (this is likely to be 99%+, but more evaluation is needed). Use as an additive flame retardant has been reported in polymers – mainly polypropylenes and polyamides) but in extremely small, niche applications – it is not a standard flame retardant for these materials.
 
Automotive data is collected throughout the supply chain using the International Material Data System (IMDS) – during our analysis TBBPA usage is grossly exaggerated, as it is not reported in the reacted form for thermosets.  This is most likely because a clear CAS number is not known for the final reaction product.  This situation may also impact other industries and could lead to a gross over reporting of TBBPA usage in Article 33 obligations and SCIP notifications, should it be classed as an SVHC. As a result, an SVHC listing would have unintended consequences for the automotive industry
 
As the automotive industry is only impacted by additive applications, alternative risk management options are preferred to listing TBBPA as an SVHC: the unacceptable uses could be regulated by an Annex XVII Restriction.	Thank you for your comments and the information provided.
Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process, and possibly an Annex XVII restriction.

The justification for SVHC identification is based on intrinsic properties of the substance, not on use, exposure and risk. 

We also take note of this comment concerning SCIP. However, it is not directly relevant for SVHC identification which is based on the intrinsic properties of the substance and not on risk management considerations.	
				
5683
2022/10/17	ICL-IP Europe Coöperatief U.A. ,
Other contributor,
Netherlands	See for comments on part 2, the enclosed comment paper.	Thank you for the comments. Please see our response above.	
		See the corresponding embedded attachment in table 1 of Part I: 5683_2022-10-17 TBBPA ICL Response to Annex XV.pdf		
5689
2022/10/17	ChemSec,
International NGO,
Sweden	There are a number of alternatives available on the ChemSec Marketplace: https://marketplace.chemsec.org/alternatives/chemical/79-94-7	Thank you for your information. 
Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
				
5717
2022/10/17	CHEM Trust Europe,
International NGO,
Germany	TBBPA is the most widely used brominated flame retardant in the world. REACH registration volumes are 10 000 to 100 000 t/pa. Given its widespread use including in consumer articles it will be very important to adopt risk reduction measures as swiftly as possible.

The Commission`s restrictions roadmap from April 2022 states: ´ECHA will prepare an overall strategy on flame retardants by 2022, which will support COM when it decides to request (a) restriction dossier(s). The substances in scope are in principle all flame retardants, and there will be particular focus on brominated flame retardants and their prioritisation for restrictions.´

There should be no further delays with taking regulatory action. The concern regardingTBBPA is not new: Already in 2005 WWF reported findings of TBBPA in blood samples of its 3 generation human biomonitoring study: The flame retardant TBBP-A, used in printed circuit boards in electronic appliances, was found in 18 family members (3 grandmothers, 7 mothers and 8 children). The young generation has the highest median level of this chemical and the highest level was found in a child.
https://chemtrust.org/wp-content/uploads/Generationsx_wwf_2005.pdf

TBBPA has also been detected in environmental samples in the Arctic (see e.g. Vorkamp et al: Current-use halogenated and organophosphorous flame retardants: A review of their presence in Arctic ecosystems, Emerging contaminants 5 (2019), 179-200.
	Thank you for your support.

Thank you for your comments and the information provided.
Comments regarding use, exposure, biomonitoring, alternatives and risks may, where relevant, be considered at later stages of the risk management process.